Caregiver BurdenI-CARE 2NCT05733520
I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
A study testing Brain CareNotes and Dementia Guide Expert in people with Caregiver Burden and Alzheimer Disease, run by Indiana University at 2 sites in United States.
Trial summary
This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden, Alzheimer Disease
- What is being tested?
- Brain CareNotes and Dementia Guide Expert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2023to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Caregiver Inclusion Criteria:
- Self-identified primary unpaid caregiver of a person diagnosed with ADRD (at any stage) who are:
- Receiving primary care and
- Community-dwelling;
- English literate;
- Age ≥ 18 years
Caregiver Exclusion Criteria:
- Care recipient is a permanent resident of an extended care facility (nursing home);
- Involvement in another clinical trial that would prevent or interfere with study objectives;
- Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IU Health
Indianapolis, Indiana, 46202
Malaz Boustani, MD
- Recruiting
Community Health Network
Indianapolis, Indiana, 46203
Molly Campbell, DNP
About this study
Official title: I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.
Read the detailed description
This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial will enroll 184 caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.
The primary objective is to test the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, six, and 12 months.
The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment.
- Conditions
- Caregiver Burden, Alzheimer Disease
- Being tested
- Brain CareNotes, Dementia Guide Expert
- Keywords
- Alzheimer's disease and related dementias, Caregiver, Caregiver Burden, Behavioral and psychological symptoms of dementia
- Medical subject headings
- Caregiver Burden, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CareNotesBehavioural
The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
Dementia Guide ExpertBehavioural
Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."
| Study group | Role | What they receive |
|---|---|---|
| Brain CareNotes App | Experimental | Not described Receives: Behavioral: Brain CareNotes |
| Attention Control App | Active comparator | Not described Receives: Behavioral: Dementia Guide Expert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden
The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.
Measured: 12 months
Patient BPSD
Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.
Measured: 12 months
Secondary outcomes (3)
Caregiver Depressive Symptoms
Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item questionnaire using a 0-3 rating scale. Scores range from 0-27. A total score of 0 represents no depression, while score of 5, 10, 15, and 20 serve as cut points for mild, moderate, moderately severe, and severe depression, respectively.
Measured: 12 months
Caregiver Acute Care Utilization
Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Measured: 12 months
Patient Acute Care Utilization
Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start30 May 2023
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive the Brain CareNotes app or an attention control app.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Richard Holden, Indiana University
- Investigators
- Richard J Holden, PhD, Principal investigator, Indiana UniversityMalaz Boustani, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733520
- Sponsor's protocol ID
- 15749
- Other IDs
- R01AG078234
- Acronym
- I-CARE 2
- Status last verified
- Nov 2025
- First submitted
- 8 Feb 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
- ClinicalTrials.gov ID
- NCT05733520
- Acronym / sponsor ID
- I-CARE 2 / 15749
- Conditions
- Caregiver Burden, Alzheimer Disease
- Keywords
- Alzheimer's disease and related dementias, Caregiver, Caregiver Burden, Behavioral and psychological symptoms of dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.
Detailed description
This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial will enroll 184 caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.
The primary objective is to test the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, six, and 12 months.
The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive the Brain CareNotes app or an attention control app.
| Arm | Type | Receives |
|---|---|---|
| Brain CareNotes App | Experimental | Behavioral: Brain CareNotes |
| Attention Control App | Active comparator | Behavioral: Dementia Guide Expert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain CareNotesThe Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities. | Behavioural | Brain CareNotes App |
| Dementia Guide ExpertDementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services." | Behavioural | Attention Control App |
Primary outcome
Caregiver Burden
Time frame: 12 months
The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.
Patient BPSD
Time frame: 12 months
Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.
3 secondary outcomes
Caregiver Depressive Symptoms
Time frame: 12 months
Caregiver Acute Care Utilization
Time frame: 12 months
Patient Acute Care Utilization
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard J Holden, PhD principal investigator
Indiana University
Malaz Boustani, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain CareNotes and Dementia Guide Expert in people with Caregiver Burden and Alzheimer Disease, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam J Rodriguez, PhD ((812) 856-1661, mijrodri@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Burden (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.